dcsimg FDA Regulatory - Life Sciences

Life Sciences - FDA Regulatory

McGuireWoods provides strategic navigation in the turbulent waters of U.S. Food and Drug Administration (FDA) oversight. Our mission is to solve problems efficiently, add value and implement strategies that help clients achieve their ultimate goals.

The FDA team at McGuireWoods comprises a core group of experienced, FDA-focused lawyers. Our group includes two former members of the FDA and National Institutes of Health (NIH), a former in-house counsel to a medical device company, and various lawyers active in the tobacco, food and beverage, nutraceutical, and consumer product industries. By maintaining a positive relationship with the FDA, our team is able to keep clients informed on changes to regulatory policies and procedures. We also receive daily briefings from news banks around the United States, the content of which we distill and share with clients. Topics range with emerging news, but have included updates on evolving legislation from Capitol Hill, recent judicial opinions and emerging FDA policy.

Our FDA practice represents life science companies with interests and operations across the United States and around the world. We have counseled national and multinational manufacturers and distributors of medical devices, drugs, food, cosmetics, nutritional supplements and veterinary products.

We regularly advise clients on all aspects and at all stages of FDA submissions, marketing and promotional campaigns, compliance counseling, regulatory and compliance analysis, liability analysis, corrective action plans and litigation. In addition to drafting or reviewing documents required to obtain approval of new products, we guide our clients in the highly scrutinized area of product promotion, often reviewing advertising and marketing initiatives for FDA and Federal Trade Commission (FTC) compliance. We also draw on the resources of our full-service public affairs subsidiary, McGuireWoods Consulting, to provide strategic communications and government relations services.

Litigation prevention is a valuable business investment in today’s market, and we regularly advise clients on risk-management and litigation-avoidance strategies. When business disputes, government investigations or law enforcement actions arise, our team provides a strong defense at every stage of pre-trial, trial and appellate processes. We have defended individuals and companies in various types of FDA-related litigation, including grand jury investigations, criminal prosecutions, and civil regulatory and enforcement matters in federal and state courts. Among other matters, we have represented companies in numerous seizure and injunction actions; for example, we recently defended the mass seizure of a major medical device manufacturer’s products, saving inventory worth tens of millions of dollars.

With respect to day-to-day FDA compliance, we assist clients with developing standard operating procedures (SOPs) to comply with FDA directives and current Good Manufacturing Practices (cGMP), quality system regulation (QSR) and inspections, as well as compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We analyze client compliance positions against FDA regulatory requirements and policies. We also assist clients with understanding their current compliance positions, and develop regulatory solutions that meet both their compliance requirements and business needs.


Brian J. Malkin Senior Counsel T: +1 202 857 1704
Stephanie A. Kennan Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC T: +1 202 857 2922
Matthew Hall Matthew Hall
rue des Colonies 56 - box 3
1000 Brussels

T: +32 2 629 42 34
F: +32 2 629 42 22
Brian Malkin Brian J. Malkin
Senior Counsel
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 1704
F: +1 202 828 2964
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6th Annual Medical Device and Life Sciences Conference

Tuesday, November 18, 2014
Chicago, IL
Speaking Engagement

Legal and Regulatory Summit on Generic Drugs

July 24-25, 2014
New York, NY
Speaking Engagement

5th Annual Conference on Biosimilars

June 4-6, 2014
New York, NY
Speaking Engagement

BioCentury This Week

Safety v. Competition (Federal Trade Commission Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition February 4, 2014 Overview)

February 16, 2014
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Results 1-13 of 13
Legal Alert

FDA’s Recent Two-Pronged Attack on Drug Shortages

Four Things to Know about FDA’s Proposed Rule

December 11, 2013
Legal Alert

Drug Quality and Security Act

What You Need to Know

December 4, 2013
Legal Alert

FDA Seeks to Tighten Drug Import Regulation

August 9, 2013
Legal Alert

FDA Attempts To Secure The Border

Proposed FSMA Rules Aim To Even Playing Field Between Domestic And Foreign Food Suppliers

August 6, 2013
Legal Alert

New FDA Guidance on Medical Devices

Enhanced Reporting Requirements for Adverse Events

August 1, 2013
Results 1-13 of 13